The Politics of Intellectual Property Rights and Access to Medicines

On Wednesday, May 23, the main UN body for health passed a new resolution on public health, innovation and intellectual property. The resolution was applauded by the public health community, and was supported by all WHO member states, except one -- the United States.

Earlier, on May 10, 2007, Speaker Nancy Pelosi and Ways and Means Chair Charles Rangel announced a "new bipartisan" trade package that addressed some of these same issues. The new agreement between the House Leadership and the Bush Administration on trade policy included a section on intellectual property rights (IPR) and access to medicine in developing countries.

The Rangel/Pelosi trade deal addressed a wide number of issues, and drew lots of fire from groups who opposed various elements, including Huffpo blogger David Sirota. Some health activists were highly critical of the provisions on IPR and access to medicines in developing countries. On this aspect of the deal, our impression was more favorable.

Rangel and Pelosi were able to deliver some substantial changes in trade policy on three highly technical but very important issues. As set out in this analysis, in every case, the new trade agreement reduces barriers to the use of generic medicines in poor countries. I agree with the groups that wanted more from the Democrats. But I was perhaps more impressed with how much was achieved in this first step toward a new trade agenda. I hope it is not the last.

The fact that the new trade deal was an agreement with the Bush Administration means it involved compromises. On the issue of IPR and access to medicines, any concessions that would help poor people living in poor countries were bitterly opposed by the pharmaceutical industry, a tough lobby in this town. The drug companies not only have huge sway with the Republicans, they have a lot of influence with Democrats, including those who are making speech after speech on the need to protect our intellectual property. The new trade deal addressed the most important three issues in the current trade deals with poor countries (linking patents to drug registration, patent extensions beyond 20 years, and the new IPR right in pharmaceutical test data). The Bush administration made real concessions, and patients will benefit from this.

The World Health Assembly (WHA) is the main governing body for the UN's World Health Organization. The passage of resolution WHA60.30 last week was both (a) another indication the current trade system is broken, and (b) a hope for a new and better paradigm that will serve everyone's interest better.

The WHO debate on IPR and medicines is quite important, but virtually unknown in the one country where it is most important -- the United States. Few members of Congress are following the debate, and there has been zero press coverage. In Europe and in developing countries, more is known. In the past several months there have been high level meetings on these issues held or scheduled in Geneva, Paris, the Netherlands, Munich and Brussels. The European Parliament has engaged. The U.S. Congress has not.

Last week the WHA resisted the pressure from the Bush Administration and gave the WHO a fresh mandate to provide technical assistance to poor countries who want to issue compulsory licenses on patents on medicines or take other measures to promote access to generic medicines. But they did not stop there. The WHO is debating the need for a new approach for financing new drugs, one that does not "link" R&D incentives to drug prices. Here, the Bush administration has not been horrible, at least in the past year. But, nothing will really change unless there is more leadership from the United States.

This is the basic deal. A number of public health experts, groups and government officials are now saying it is a mistake to have a global trade framework that is devoted to higher drug prices as the primary or only instrument to promote global medical R&D.

* First, they argue the trade framework should be refashioned as agreements to pay for R&D, and that countries should be free to choose all sorts of ways to do that, including public sector funding of open source R&D projects, uses of innovation prizes, or other innovative ways to finance R&D. This new trade framework should deal both with the sustainable sources of finance, and make real efforts to address priority setting, including efforts to ensure adequate investment in treatments that concern illnesses that disproportionately impact poor people living in poor countries.

* Second, they argue that private R&D incentives should not be linked to drug prices at all, and that rewards for innovation in new products should be more closely tied to evidence that the products actually improve health care outcomes. A number of countries are now calling for broader uses of prizes to stimulate innovation, an idea that is gaining traction in a number of different areas these days, including not only to stimulate R&D for new medicines, but also for a number of other public goods.

This new debate over the global framework to support medical innovation is important, and one that should be on the radar screen here -- in the country that is:

1. The biggest global bully for big pharma, and increasingly isolated in world public opinion, as illustrated by last week's WHA decision.
2. The biggest funder of medical R&D in the world, including both private sector and public sector investments.
3. The biggest purchaser of generic AIDS drugs in the world.
4. The most in need of domestic reform to control drug prices, among high income countries.